FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions
By EsqSocial Corporation 06/08/14
On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating Substantial Equivalence in...
By: Ropes & Gray LLP